OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

CooperVision, Inc. recalls Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
CooperVision, Inc.
Reason
The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of FL, KY, MI.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99936…

Products

  1. Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged.

    Codes/lots: Model/Catalog Number: Softmed Breathables Advanced Toric; UDI-DI: N/A Lot numbers: 19486120027517, 19486120030515, 19486120035532, 19486120051506, 19486170015507, 19486170016513, 19486170016521, 19486170017507, 19486170017509, 19486170017512, 19486170019512, 19486170019514, 19486170021021, 19486170021518, 19486170022503, 19486170022504, 19486170023528, 19486170025508, 19486170026021, 19486170027034, 19486170027504, 19486170027524, 19486170028518, 19486170030023, 19486170030034, 19486170031023, 19486170031034, 19486170032030, 19486170032036, 19486170032504, 19486170033501, 19486170034001, 19486Quantity: 230856Recall no. Z-0204-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls